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..... kind of reminds me of the trouble Dr.Zamboni had-has with getting his larger clinical trial up and running in Italy. I suspect Dr.Siskin wants to proceed in one direction , but the money people want to go down another path.

I guess the problem was not having enough local people. Dr. Siskin has been treating people in Albany for three years now, maybe the people who wanted it done have already had it done? A lot of patients being seen by IRs are repeat patients, not first-timers. I don't understand the FDA's intentions with this and with Dr. Hubbard's CCSVI registry. Even if it isn't a large enough trial, wouldn't the information gathered be of use? This leaves us with Dr. Zamboni's trial and Dr. Trabalousee's. I would have more confidence in Dr. Trabalousee's trial if his IR had done 400 CCSVI procedures prior to starting the trial, since that is the learning curve identified in the recent 1200 patient study where most of the adverse events occurred within the first 400 patients. Dr. Zamboni's trial seem like a multi-institutional effort being tugged in more than one direction by the different people involved. I want to get from here to there, with here being this state of CCSVI unproven and there being CCSVI proven to exist and to warrant treating.

Siskin said he believes there are two reasons for the lack of volunteers.

One is that some physicians question the therapy and didn't push patients to join the trial.

The second is that it was a double-blind trial — meaning half of those participating would have received liberation therapy and half would get a placebo procedure. The patients would not know which one they got for several years.

"It's easy to say that everyone would do it if they knew that they would all get treated," he said. "But if only half the patients were to get treated and half the patients would undergo a sham procedure, not everyone is always willing to do something like that."

Y'know I didn't want to join a trial either. I wanted more control over knowing I'd get the procedure and also choice of doctor. But would the trial have been free to participants? That's an incentive. If the length of time is a disincentive, then trial design goes back to the drawing board. A three month trial is long enough to test the effect of CCSVI treatment on CCSVI syndrome. A 2 year trial is more for testing the effect of CCSVI treatment on MS. Will Dr. Siskin revise and try again a new trial, or will he leave the research for someone else to do? I hope he revises and tries again.

On Facebook someone posted from the text of the letter that was sent out:

"Clinical trial lead, Dr. Gary Siskin, has advised the Ministry of Health that he was unable to meet the target enrolment necessary for the study to produce statistically valid results. Despite Saskatchewan’s 86 planned participants, the research team could not recruit enough total participants to meet United States government requirements for a clinical trial."

UPDATE on Cancelled Trial from CTV News--"Siskin told CTV News that he’s “very disappointed” the trial had to be cancelled.

He spoke about the difficulty in getting people to enrol in the study, as participants seemed reluctant because of the 50/50 chance that they would receive a placebo treatment instead of the real thing.

Siskin, an interventional radiologist, has treated several hundred patients outside of the trial -- but he stopped in favour of doing formal research into the treatment. His was the only FDA-approved study for CCSVI therapy.

He says despite the setback, his interest in CCSVI is undeterred. "This in no way diminishes my interest in CCSVI," he said.

He told CTV News that in his opinion, narrowed veins in patients with symptoms of MS "is a diagnostic entity” and is “real.”

"I've seen too many people who have responded to treatment to say they are making it up," Siskin said.

Saskatchewan Health Minister Dustin Duncan also expressed disappointment at the news for the approximately 3,500 MS sufferers in his province.

“Our government wants to do everything it can to search for answers and further the science for people with MS,” said Duncan. “That’s why Saskatchewan was supportive of this trial and will continue to be supportive of research that may provide answers for those with MS and their families.”

Dr. Siskin has been following the FDA's requests. They felt he needed 200 patients for his trial to be statistically significant. (How, exactly, would he find 200 people with MS, who met the trial parameters, who would undergo venoplasty and not know the outcome? He didn't.) They do not allow treatment outside of trials. The FDA made the call. They have not approved the Hubbard's registry (yet). It is a Catch 22 situation.

We need to realize that the BNAC trial, with 16 people, never had FDA approval. Yet it is being touted as THE double blind, placebo controlled trial....although a paper has never been published, and it only was reported as a poster. Whereas, Dr. Siskin requested FDA approval, and this is what happened.

I would just like to echo Cheer. Dr Siskin is an excellent doctor and researcher as well as a very nice person. I know that if he could have made this work he would have. Now the concern is that the next researchers will probably be using far less well qualified IR's who have not treated several hundred people and climbed the learning curve.

I believe that I was about Dr Siskin's hundredth patient and that was 3 years ago next week so I assume he has treated several hundred patients by now.

Maybe I'm stupid, but I waited 1 year for admin staff to be hired, 1 year of washout, all with no DMDs, to be on a 2 year trial where I got placebo. I would have stayed on it but they cut it short because it didn't work. I had a heart attack near the end of it. Probably a delayed reaction to mitoxantrone. The neurologists claimed there was no other treatment I could take. They had been claiming that for two years already. So four years of no treatment. I stayed on it and did my bit for science. One doctor even thanked me (imagine that -- not one of the usual suspects). After that Dr. Zamboni was on CTV. 1 year later Dr. Siskin treated me.

In all that time, I experienced significant progression. But guess what? I would volunteer for the Saskatchewan trial, and travel on my own nickel, if he hadn't already treated me. CCSVI is that important.

I have no standing to say this, but:

Needed immediately: 400 volunteers for trial in Albany NY., 200 with, 200 without "MS". Must provide own transportation to and from Albany, N.Y. If you are on DMDs you can stay on them. 50% chance of immediate treatment. The other 50% will get a sham venoplasty procedure. After 2 years if the treatment proves successful, placebo patients will be treated, either by an experienced local doctor, or an experienced Canadian doctor. Pass it on. Pay it forward.

I am not a doctor. This is being posted to see if enough people would volunteer.

This unit of entertainment not brought to you by FREMULON.Not a doctor.

I think it's too late, 1eye. Now we wait for news of what other US trials or registries are planned. Dr. Siskin might join up with one of those.

The Saskatchewan government had committed $2.2 million to have 86 patients from the province take part in the trial. However, it was difficult to find people with MS who met the study criteria and were willing to be part of a placebo controlled trial. Many patients want to know that they are being treated, rather than risk an invasive venoplasty procedure without treatment. Participants in this trial would not know whether or not they had been treated for CCSVI, and this may have made patients resistant to enrolling for participation. Funding for and patient interest in the American patient arm of the trial was also an issue. Because of these factors, the Albany Medical Center team decided to stop the trial.

Funding was also an issue. Did they plan for a smaller study but then had to go with a bigger one when the FDA set the standard of a high number of participants? This trial has been at least 3 years in the making. It was submitted to clinicaltrials.gov back in Sept 2010.http://clinicaltrials.gov/ct2/show/NCT0 ... SVI&rank=2In the summer of 2010, Dr. Siskin was the only outed IR openly treating CCSVI. That was an alarming time because we began to get reports of clots in some patients and lost veins, which hadn't really been on the radar prior to that. But that was three years ago and the IRs have had the opportunity to refine their techniques. There are countless positive reports about Dr. Siskin, and I am convinced he is an excellent doctor.

Never say never. They were probably discouraged by the Fear Uncertainty and Doubt Administration, and thought they might not get enough Americans without advertising. If they relied on referrals from suspicious doctors, they could never get anywhere, since it would have to come from a neurologist in most cases. This restriction to the prospective, along with the requirement that it be double blinded before anyone will take off their supposedly scientific blinkers, puts the "MS" patient just where drug companies want them: at the mercy of their "special"-ists, some of whom apparently take bribes from drug companies.

What I was doing was trying to publicize it, appealing to those who can still think for themselves, and the caregivers of those people, to take a chance, to stand up and be counted. If enough people passed it on, and paid it forward, maybe it would acquire its own momentum.

This unit of entertainment not brought to you by FREMULON.Not a doctor.

as disappointing as it is .... the CCSVI movement will continue to move forward. With or without Dr.Siskin. He is only one of MANY. And therefore should feel pretty good about all that he has provided . I see CCSVI as a relay race. No one person goes it the whole way.

I applaud Dr.Siskin for all of the ground he has gained for CCSVI.

I still can see no logic in performing sham procedures. How is that possible ?

It is the Neurological World that dreams up such boffo ideas. They tried screaming IT's UNSAFE ! ..... and that has methodically been proven wrong. It is safe. End of that story.

They now cling to the placebo theory . How sad. What poor science. Shameful in fact.

This placebo thingamajig nonsense...... will be overcome also. This hurdle is low. But we will play along . And carry on.

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